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Cranial Electric Stimulation to Modify Suicide Risk Factors in Psychiatric Inpatients.

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ClinicalTrials.gov Identifier: NCT02846740
Recruitment Status : Terminated (No finding at halfway point of the study)
First Posted : July 27, 2016
Last Update Posted : January 25, 2018
Sponsor:
Information provided by (Responsible Party):
Nithin Krishna, University of Maryland

Brief Summary:
This pilot study aims to investigate whether a treatment called cranial electric stimulation or CES can decrease risk factors for suicide. The specific CES device we will use is called Alpha-Stim®. CES will be used in addition to usual treatment (medication and group therapy).

Condition or disease Intervention/treatment Phase
Suicide Depression Anxiety Insomnia Agitation Device: Alpha-Stim®. Behavioral: Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale Not Applicable

Detailed Description:
Suicide is still a major issue in the United States and all around the world. There are many reasons for people attempting suicide and the major modifiable risk factors are depression, anxiety, insomnia, and agitation. The standard treatment for all suicidal patients includes medication, admission to a hospital and reducing the risk factors. Medications have potential side effects and concerns about the drug interactions. One of the biological treatment alternatives to medication is cranial electric stimulation. This technique uses a device to stimulate the brain through electrical current. Using an Alpha-Stim® device, current is applied to the brain using skin electrodes which can be easily clipped on to the earlobe. The amount of current used is very low and is 1/1000 th of the current used for electroconvulsive therapy (ECT) and 1/10 th to 1/20 th of the 1-2 milliamperes used with transcranial direct current stimulation (tDCS). Our goal is to examine the safety and efficacy of this device when used as an add-on or adjunctive treatment to the usual treatments during the inpatient stay.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cranial Electric Stimulation to Modify Suicide Risk Factors in Psychiatric Inpatients
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : January 22, 2018
Actual Study Completion Date : January 22, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Suicide

Arm Intervention/treatment
Experimental: Adjunctive CES
CES 100µA for one hour daily, five to seven days per week. Rating scales will be administered at baseline (i.e., pre-treatment), twice a week and at the end of the study.
Device: Alpha-Stim®.
cranial electrical stimulation

Behavioral: Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale
A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).

Sham Comparator: Sham control CES
For the sham group the Alpha-Stim® will not emit electricity. All other procedures will be the same for both the sham group and the active CES group. The current intensity will be preset and locked by the manufacturer. The sham devices will appear identical to the active device.
Device: Alpha-Stim®.
cranial electrical stimulation

Behavioral: Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale
A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).




Primary Outcome Measures :
  1. Change in the modifiable suicide risk factors (MSRF's) [ Time Frame: 2 years ]
    To assess the efficacy of adjunctive cranial electric stimulation (CES), specifically Alpha-Stim®, to reduce suicide risk in psychiatric inpatients through a randomized, double-blind, sham-controlled, clinical trial. The primary efficacy outcome measure will be change in the modifiable suicide risk factors (MSRF's) as indicated by a summed global score from rating scales measuring the MSRFs that include depression (Montgomery-Åsberg Depression Rating Scale), anxiety (Hamilton Anxiety Rating Scale), insomnia (The Pittsburgh Sleep Quality Index) and agitation (Agitated Behavior Scale).

  2. Assess adverse effects and safety [ Time Frame: 2 years ]
    To assess safety of adjunctive cranial electric stimulation (CES), specifically Alpha-Stim®, to reduce suicide risk in psychiatric inpatients through a randomized, double-blind, sham-controlled, clinical trial. The primary safety outcome measure will be responses to an adverse effect assessment questionnaire (GASE questionnaire).


Secondary Outcome Measures :
  1. Assess length of stay [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject must be a patient admitted voluntarily to the UMMC adult psychiatric inpatient services with suicidal thoughts / intent / plan or suicide attempt who also has MSRFs including anxiety, agitation, insomnia, and/or depression).
  2. Subject must be between the ages of 18 and 65 (inclusive). Both men and women will be included
  3. Subjects who are female must have a negative pregnancy test prior to enrolling in the study, and must be practicing at least one or more the following methods of contraception during the study: intrauterine device (IUD), barrier method in combination with a spermicide, or oral/hormonal contraception or abstinence, which is typically the case on the inpatient units.
  4. If a subject has a substance abuse disorder, they must also have another non-substance abuse psychiatric disorder as determined from the clinical history.
  5. Chronic medical conditions such as endocrine disease, hypertension, renal disease, must be stable.
  6. Subject must be capable of giving informed consent. Subject must provide written informed consent prior to study participation.
  7. Subject must be capable of doing active or sham CES treatments and completing all study requirements.

Exclusion Criteria:

  1. Subject has a significant medical disorder with acute symptoms which could impair reliable participation in the trial or affect their MSRFs.
  2. Subject is pregnant.
  3. Subject has had concomitant therapy with another investigational drug, or participation in an investigational drug study within one month prior to entering this study.
  4. Subject has a clinical history of poor compliance or in the investigator's judgment participation in the study would be clinically contraindicated.
  5. Subject has current or past behavior that suggests to the investigator that his/her suicidal behavior is driven by secondary gain, i.e. expressing suicidal thoughts so that s/he can be admitted due to homelessness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846740


Locations
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Nithin E Krishna, MD University of Maryland

Responsible Party: Nithin Krishna, Assistant Professor of Psychiatry, University of Maryland
ClinicalTrials.gov Identifier: NCT02846740     History of Changes
Other Study ID Numbers: HP-00065640
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Nithin Krishna, University of Maryland:
cranial electric stimulation
suicide
psychiatric inpatients

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms